ABSTRACT Maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV-1 prevention. In Africa, PrEP will be added to an already-burdened health infrastructure and the ability of the health systems to maximize PrEP access will necessitate finding novel delivery strategies. In feasibility evaluations of PrEP delivery in Africa to date, major barriers to PrEP delivery include stigma, long waiting times, and the costs of staffing at public health clinics. In Kenya, retail pharmacies fill an important gap in the medical system and pharmacy-delivered care has many attributes that may be desirable for potential PrEP users, potentially including increased convenience, anonymity, and engagement. The core components of PrEP delivery ? including HIV testing, adherence and risk reduction counseling, assessment of side effects, and provision of refills ? are within the scope of practice for pharmacists in Kenya. We hypothesize that pharmacy-based PrEP delivery will be feasible in Kenya and that individuals will successful uptake PrEP at pharmacies and be retained in care. With a multidisciplinary collaborative team, we will conduct research on the feasibility of pharmacy-based PrEP delivery in Kenya, develop a care pathway for this delivery model, pilot this model in two study sites (i.e., Kisumu and Thika), and identify potential weak points of the care pathway that can be adapted. Our formative research will include qualitative interviews with potential pharmacy- based PrEP consumers and providers as well as meetings with key stakeholders; a care pathway for PrEP delivery in pharmacies will be developed from these findings. In the pilot, we will initiate 150 persons on PrEP at four pharmacies (~25-50 persons/pharmacy, 2 pharmacies/study site). Pilot pharmacists will follow the care pathway we developed for PrEP delivery from the formative work, which will include counseling, HIV testing, prescribing, and refilling (all overseen by a remote physician). All participants that initiate PrEP at the pilot pharmacies will be instructed to return to the pharmacy at months 1, 3 and 6 for follow-up care, including HIV testing and refilling PrEP drugs. The primary pilot outcomes will be PrEP initiation, retention in care, PrEP adhere (including objective measures), and safety (including management of side effects and social harm). We will also measure participants? and pharmacists? experiences with pharmacy-based PrEP delivery using qualitative interviews and willingness to pay for PrEP at pharmacies using quantitative surveys. The delivery of PrEP at pharmacies has never been tested in sub-Saharan Africa, and has the potential to improve PrEP?s reach, impact without sacrificing HIV-1 protection and safety, and cost-effectiveness. The results of this R34 will inform a potential cluster-randomized trial to test pharmacy-based PrEP at scale. Given the time-sensitive nature of this question, and leveraging our experience, we propose to conduct this work in 2 years.